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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
As the QC Microbiology Supervisor, you will:
Lead daily lab operations-including oversight of environmental monitoring, microbial testing of utilities (USP <61>, <62>, <85>), and in-process/final product testing Supervise, mentor, and develop a high-performing team of microbiologists and lab personnel Manage scheduling, workloads, and ensure timely testing and release of all microbiological samples Perform risk assessments and investigations (EM excursions, aseptic incidents) and implement effective CAPAs Perform data trending and statistical analysis; author quarterly reports on environmental and utility data Oversee testing for endotoxins, bioburden, growth promotion, EM sampling, and clean utility sampling Collaborate cross-functionally with Operations and Facilities to protect aseptic integrity Support and coordinate equipment validation, calibration, and maintenance Drive compliance with cGMP, FDA, EU, and international microbiology regulations Review and author SOPs, support method development, and guide test execution to regulatory expectations
Who You Are
You bring not only technical microbiology expertise but also strong leadership skills and a desire to coach, inspire, and elevate your team. You're a critical thinker with a strong quality mindset who enjoys solving complex problems and helping ensure patients receive safe, effective products.
Qualifications
Education & Experience:
Master's degree in Microbiology, Biology, or related life science (preferred) OR Bachelor's degree with 5+ years of progressive GMP QC Microbiology experience 1-3+ years in a leadership role within a QC Microbiology lab Hands-on experience with aseptic processing, environmental monitoring, and USP microbiological testing required Skilled in data analysis and report writing
You'll Stand Out If You Have:
In-depth understanding of ISO cleanroom classifications and GMP clean utility systems Strong knowledge of U.S. and international microbiology regulations Experience with media qualification, microbial identification, and root cause investigations
What We Offer
Opportunities for growth and advancement within a science-driven, patient-focused organization A collaborative, team-oriented environment with cross-functional exposure The chance to make an impact on public health by ensuring the safety of every batch Ongoing training and development to keep your skills sharp in a fast-evolving industry
Additional Requirements
Must be able to work across NH PCI sites, including remote locations Ability to gown for ISO-classified cleanroom work Ability to lift up to 20 lbs Occasional off-shift support may be required #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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PCI Pharma Services
Jul 06, 2025